Topical Remetinostat Gel as Neoadjuvant Therapy in Patients With Squamous Cell Carcinoma (SCC)

April 28, 2021 updated by: Kavita Sarin

A Phase 2 Open Label, Single Arm Trial to Investigate the Efficacy and Safety of Topical Remetinostat Gel as Neoadjuvant Therapy in Patients Undergoing Surgical Resection of Squamous Cell Carcinoma (SCC)

The primary purpose of this study is to determine if 8 weeks of topical remetinostat applied three times daily will suppress Squamous Cell Carcinoma.

Study Overview

Status

Terminated

Intervention / Treatment

Detailed Description

The primary purpose of this study is:

  • to determine if 8 weeks of topical remetinostat gel applied 3 times daily (TID) under occlusion will suppress SCC growth
  • to determine the overall response rate (ORR) of SCCs after 8 weeks of treatment with topical remetinostat gel 1%, as measured by at least 30% decrease in greatest area (in mm2).

    • Subjects with at least 1 biopsy-proven cutaneous SCC will be recruited for this study.
    • Subjects will apply remetinostat gel 1% to at least 1 SCC.
    • Non-invasive cutaneous SCC lesions, including Bowen's disease, are also eligible for this study
    • There is 1 treatment option: Topical remetinostat gel 1% applied 3 times daily.
    • The study is a single arm, open label design
    • For purposes of ClinicalTrials.gov, there is no secondary outcome.

Study Type

Interventional

Enrollment (Actual)

4

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • California
      • Stanford, California, United States, 94304
        • Stanford Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Must have at least one biopsy-proven cutaneous SCC or SCC in situ (SCC-IS) lesion greater than or equal to 5 mm. Non-invasive SCC lesion(s), including Bowen's disease (SCC-IS), are eligible, but must be amenable to surgical resection.
  2. 18 years of age or older.
  3. Must be willing to apply the topical remetinostat 3 times daily for 8 weeks and cover with an occlusive bandage.
  4. Negative serum pregnancy test within 14 days prior to the first dose of study therapy for women of child-bearing potential, defined as a sexually mature woman who has not undergone a hysterectomy or who has not been naturally postmenopausal for at least 24 consecutive months (i.e., who has had menses any time in the preceding 24 consecutive months)
  5. Sexually active women of child bearing potential (WCBP) and male patients with a female partner of child-bearing potential must agree to use acceptable methods of contraception to avoid pregnancy (for example, oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner) before the first dose of study therapy and for 3 months after the last dose of study therapy
  6. Has signed and dated the current, approved informed consent document.

Exclusion Criteria:

  1. Any large (> 20 mm) SCC lesion. Patients with large SCC lesion(s) will be referred for evaluation for surgical resection.
  2. Inoperable locally-advanced and/or non-cutaneous metastatic SCC.
  3. SCC lesion(s) in cosmetically-sensitive areas (e.g. tip of nose, eyelid) are not eligible for enrollment. (If a patient has SCC lesion(s) in other areas, those tumor(s) may be considered for enrollment.)
  4. Taking any medication known to affect SCC growth
  5. Within the past 6 months, has used topical or systemic therapies that might interfere with the evaluation of the study medication during the study. Specifically, these include the topical use at the site of the study tumors:

    • Glucocorticoids
    • Retinoids either systemically or topically at the tumor site (e.g., etretinate, isotretinoin, tazarotene, tretinoin, adapalene)
    • Alpha-hydroxy acids (e.g., glycolic acid, lactic acid) to the tumor site
    • 5-fluorouracil or imiquimod
  6. Has received treatment with systemic chemotherapy within 60 days prior to starting study medication.
  7. Currently receiving systemic medications that could affect SCC tumors (e.g., oral retinoids) or might interact with remetinostat
  8. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, recurrent seizure history or psychiatric illness/social situations that would limit compliance with study requirements.
  9. Moderate to significant immunosuppression (e.g., active cancer, significant autoimmune disease) and/or receiving immunosuppressive drugs that result in moderate to significant immunosuppression (e.g. low dose oral glucocorticoids do not necessarily exclude a patient)
  10. Known or previous hypersensitivity to HDACi
  11. History of congestive heart failure, cardiac arrhythmias, or other findings of ventricular dysfunction.
  12. Pregnancy or breast-feeding.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Remetinostat
Subjects will apply remetinostat gel 1% to at least 1 SCC: Topical remetinostat gel 1% applied 3 times daily.
Topical 1% remetinostat gel
Other Names:
  • suberohydroxamic acid phenyl ester (SHAPE); SHAPE Gel;
  • SHP-141;
  • and 4-[[8-(hydroxyamino)-1,8-dioxooctyl]oxy]-benzoic acid methyl ester

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Response (OR)
Time Frame: 10 weeks

Overall response (OR) will be assessed in squamous cell carcinoma (SCC). Objective response (OR) will defined as the number of lesions with either a complete response (CR) or a partial response (PR) among all eligible and treated lesions, any time within 10 weeks.

  • Complete Response (CR) = Disappearance of target lesion
  • Partial Response (PR) = ≥ 30% decrease in the sum of the longest diameter of target lesion
  • Overall Response (OR) = CR + PR
10 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Events Contributing to Treatment Discontinuation or Interruption
Time Frame: 8 weeks
Adverse events (AEs) contributing to treatment discontinuation or interruption are reported as the number of such events, a number without dispersion.
8 weeks
Participants Who Discontinued Treatment or Had Treatment Interruption
Time Frame: 8 weeks
The number of participants who discontinued treatment or experienced treatment interruption within the first 8 weeks of treatment are reported as the number of such participants, a number without dispersion.
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Collaborators

Investigators

  • Principal Investigator: Kavita Y Sarin, MD, PhD, Stanford University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 12, 2019

Primary Completion (Actual)

May 14, 2020

Study Completion (Actual)

January 30, 2021

Study Registration Dates

First Submitted

March 13, 2019

First Submitted That Met QC Criteria

March 13, 2019

First Posted (Actual)

March 15, 2019

Study Record Updates

Last Update Posted (Actual)

May 20, 2021

Last Update Submitted That Met QC Criteria

April 28, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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